Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.

Suicide is a major public health issue. Repeated self-harm may lead to potential future suicide deaths. In addition, it may lead to substantial loss in medical costs. Recently, smartphones have been widely used. Researchers started to apply mobile health to support individuals with self-harm experiences and to combine brief contact interventions which require lower cost to reduce repeated self-harm. However, the research evidence remains sparse. Furthermore, self-harm behaviors might be influenced by different cultural contexts. There is a need to conduct local studies in Taiwan. The aim of this study is to establish a co-design team which includes service users and service providers, to collaboratively develop a text- and web-based brief contact intervention (BCI) to reduce repeated self-harm, and to evaluate the feasibility of the intervention.

Study Overview

• Status: Recruiting
• Conditions: Suicide and Self-harm
• Intervention / Treatment: Behavioral: Brief contact intervention

Detailed Description

Study objectives:

1. To establish a co-design team and develop a brief contact intervention (BCI), including the content, frequency, settings, and outcome measures of the intervention.
2. To evaluate the feasibility of BCI, including the feasibility of recruitment, required resources, the appropriateness of data collection, and the acceptability of the BCI.

Methods:

1. In study 1, we will recruit 4-6 service users and 4-6 service providers respectively, and we will conduct focus groups to discuss the content of the BCI. We will conduct individual interviews with participants to explore their experiences and perspectives regarding their participation in the co-design team.
2. In study 2, we will recruit 30 participants who have self-harm experiences to participate in the BCI. The BCI will be delivered through texts and web pages and will last around 5 months. The content of BCI will include caring messages, reminders of appointments, safety planning, volitional help sheet, and resources information. We will collect user engagement data and compare study outcomes (e.g., suicidal ideation and behaviors, brief symptom rating scale (BSRS), and mental well-being scale) before and after receiving the BCI. We will collect the participants' feedback regarding the BCI and evaluate the required resources to further revise the BCI.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shu-Sen Chang, MD, MSc, PhD; Phone Number: +886 2 33668062; Email: shusenchang@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Shu-Sen Chang, MD, MSc, PhD; Phone Number: +886 2 33668062; Email: shusenchang@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 20 years or over
• Mentally and physically stable and able to participate in individual interviews and interventions
• Able to communicate in Mandarin and provide written informed consent
• Willing to be recorded during the interviews
• Received medical treatments or aftercare due to self-harm experiences, including self-harm ideations, self-harm behaviors, suicidal ideations, and suicidal attempts.
• Able to use the smartphone to access the internet

Exclusion Criteria:

• Mental and physical states are unstable (e.g., unconscious, severe psychiatric symptoms, strong suicidal ideations with specific suicide plans) to complete the interviews and interventions according to the health professionals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BCI group; Participants will be asked to participate in a brief contact intervention and to evaluate its feasibility, including the feasibility of recruitment, intervention resources, the appropriateness of data collection, and the acceptance of the intervention.

Behavioral: Brief contact intervention; The brief contact intervention (BCI) will send out text messages to the participants. The text messages will include caring messages, reminders of appointments, and a link to a web page. The web page is anticipated to include safety planning, volitional helpsheet, and resources information. The text messages are anticipated to send out to the participants on a weekly base for 6 weeks in a row, and then change to monthly reminders. The monthly reminders are anticipated to include caring messages, reminders of appointments, and invitations to encourage the participants to click the previous web links again. The monthly reminders are anticipated to send out to the participants three times in a row. In the final reminder, the participants will be told that this intervention is going to end. In total, the participants will receive 9 texts within 5 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The acceptability of the intervention to participants	The investigators will conduct face-to-face qualitative interviews to understand the acceptability of the intervention amongst participants.	within 6 months of study completion
The feasibility of intervention to participants	The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention amongst participants.	within 6 months of study completion
Participant recruitment	Recruitment: the proportion of participants who are eligible and invited actually consent to participate.	through study completion, an average of 1 year
Participant retention rate	The proportion of participants who can be reached by in-person or phone contact at the 1 month follow-up.	1 month
Participant retention rate	The proportion of participants who can be reached by in-person or phone contact at the 3 month follow-up.	3 month
Participant retention rate	The proportion of participants who can be reached by in-person or phone contact at the 6 month follow-up.	6 month
Number of repeated self-harm episodes (self-report)	Number of repeated self-harm episodes per person at 1 month after intervention based on self-report.	1 month
Number of repeated self-harm episodes (self-report)	Number of repeated self-harm episodes per person at 3 month after intervention based on self-report.	3 month
Number of repeated self-harm episodes (self-report)	Number of repeated self-harm episodes per person at 6 month after intervention based on self-report.	6 month
Number of repeated self-harm episodes (nationwide self-harm registry)	Number of repeat self-harm episodes per person at 1 month after intervention recorded in the nationwide self-harm registry	1 month
Number of repeated self-harm episodes (nationwide self-harm registry)	Number of repeat self-harm episodes per person at 3 month after intervention recorded in the nationwide self-harm registry	3 month
Number of repeated self-harm episodes (nationwide self-harm registry)	Number of repeat self-harm episodes per person at 6 month after intervention recorded in the nationwide self-harm registry	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy and stages of change questionnaire	Access participants' self-efficacy and stages of change in relation to suicide ideation and attempt at 1/3/6 month.	1 month, 3 months, 6 months
Help-seeking behavior questionnaire	Assess the help-seeking behaviors of participants at 1/3/6 month.	1 month, 3 months, 6 months
Brief Symptom Rating Scale (BSRS)	Briefly evaluate the psychological distresses of participants at 1/3/6 month. The total score ranges from 0 to 25. Categorized as "mild" with score 6-9, "moderate" with score 10-14, and "severe" with score more than 15.	1 month, 3 months, 6 months
The World Health Organisation- Five Well-Being Index (WHO-5)	Measure the current mental wellbeing of participants at 1/3/6 month.	1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Shu-Sen Chang, MD, MSc, PhD, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: psychological intervention; self-harm
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Self-Injurious Behavior
• Other Study ID Numbers: 202206137RINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No